A combined analysis of data to identify predictive factors for spermatogenesis in men with hypogonadotropic hypogonadism treated with recombinant human follicle-stimulating hormone and human chorionic gonadotropin.
OBJECTIVE
To compare the efficacy and safety of recombinant human FSH (r-hFSH) and hCG treatment for male hypogonadotropic hypogonadism (HH) in different populations and to identify characteristics predictive of spermatogenesis.


METHODS
A combined analysis of data from four clinical trials.


METHODS
Phase III, open-label, noncomparative studies with similar designs conducted in Australia, Europe, Japan, and the United States.


METHODS
One hundred men with complete idiopathic or acquired HH.


METHODS
Pretreatment with hCG for 3-6 months, followed by combination therapy with hCG and r-hFSH (150 IU three times weekly) for up to 18 months. Doses of r-hFSH were adjusted according to spermatozoa count until the maximum dose was reached.


METHODS
The primary efficacy endpoint was a spermatozoa concentration of >or=1.5 x 10(6)/mL.


RESULTS
A total of 81 men remained azoospermic but achieved normal serum T concentrations after hCG pretreatment. Of these, 68 (84.0%) achieved spermatogenesis and 56 (69.1%) achieved spermatozoa concentrations >or=1.5 x 10(6)/mL. Large baseline mean testicular volume, low body mass index, and advanced sexual maturity were predictors of good response to therapy. Similar treatment responses were observed across different study populations.


CONCLUSIONS
R-hFSH (combined with hCG) is effective for the restoration of fertility in the majority of men with HH.
Warne
David W
DW
Merck Serono International SA, Geneva, Switzerland. david.w.warne@merckserono.net
Decosterd
Genevieve
G
Okada
Hiroshi
H
Yano
Yumiko
Y
Koide
Nakako
N
Howles
Colin M
CM
D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000008:administration & dosage*; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage*; D006801:Humans; D007006:Hypogonadism / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009845:Oligospermia / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D013076:Sperm Count / Q000379:methods; D013091:Spermatogenesis / Q000187:drug effects*; D016896:Treatment Outcome; D055815:Young Adult
D006063:Chorionic Gonadotropin; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone